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BEYAZ Drug Patent Profile

When do Beyaz patents expire, and what generic alternatives are available?

Beyaz is a drug marketed by Bayer Hlthcare and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in BEYAZ is drospirenone; ethinyl estradiol; levomefolate calcium. There are eleven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol; levomefolate calcium profile page.

DrugPatentWatch^® Generic Entry Outlook for Beyaz

Annual sales in 2021 were $8mm indicating the motivation for generic entry (peak sales were $68mm in 2015).

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for BEYAZ

US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	2
Patent Applications:	8
Drug Prices:	Drug price information for BEYAZ
Drug Sales Revenues:	Drug sales revenues for BEYAZ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BEYAZ
What excipients (inactive ingredients) are in BEYAZ?	BEYAZ excipients list
DailyMed Link:	BEYAZ at DailyMed

See drug prices for BEYAZ

See drug sales revenues for BEYAZ

Paragraph IV (Patent) Challenges for BEYAZ

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BEYAZ	Tablets	drospirenone; ethinyl estradiol; levomefolate calcium	3 mg/0.02 mg/ 0.451 mg and 0.451 mg	022532	1	2012-11-13

US Patents and Regulatory Information for BEYAZ

BEYAZ is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	BEYAZ	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022532-001	Sep 24, 2010	AB	RX	Yes	Yes			Y
Bayer Hlthcare	BEYAZ	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022532-001	Sep 24, 2010	AB	RX	Yes	Yes			Y

Expired US Patents for BEYAZ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	BEYAZ	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022532-001	Sep 24, 2010
Bayer Hlthcare	BEYAZ	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022532-001	Sep 24, 2010
Bayer Hlthcare	BEYAZ	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022532-001	Sep 24, 2010
Bayer Hlthcare	BEYAZ	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022532-001	Sep 24, 2010

International Patents for BEYAZ

See the table below for patents covering BEYAZ around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	188250	GRANULES COMPRISING A COMPLEX BETWEEN AN ESTROGEN AND A CYCLODEXTRIN HAVING A RELATIVE HUMIDITY OF AT THE MOST 60% AND BEING ESSENTIALLY FREE OF POLYVINYLPYRROLIDONE
Austria	451372
Norway	20032805
South Korea	100369206

Supplementary Protection Certificates for BEYAZ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
2588114	LUC00227	Luxembourg		PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 31332 20191022
0398460	SPC/GB04/032	United Kingdom		PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
3632448	22C1031	France		PRODUCT NAME: DROSPIRENONE; NAT. REGISTRATION NO/DATE: NL49691 20191121; FIRST REGISTRATION: DK - 61678 20191016

BEYAZ Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Beyaz

Introduction

Beyaz, a unique oral contraceptive developed by Bayer HealthCare Pharmaceuticals, was approved by the U.S. Food and Drug Administration (FDA) in 2010. This drug combines the hormonal ingredients of the popular contraceptive YAZ with levomefolate calcium, a form of folate, to not only prevent pregnancy but also to raise folate levels in women, reducing the risk of neural tube defects.

Market Indications and Approval

Beyaz is approved for four key indications:

• Prevention of Pregnancy: With an effectiveness rate of 99% when taken as directed[1].
• Treatment of Symptoms of Premenstrual Dysphoric Disorder (PMDD): For women who choose the pill for birth control[1].
• Treatment of Moderate Acne: For women at least 14 years old who have started menstruating and choose the pill for birth control[1].
• Raising Folate Levels: To reduce the risk of neural tube defects in a pregnancy conceived while taking Beyaz or shortly after discontinuing it[1].

Clinical Development and Efficacy

The FDA approval of Beyaz was based on a pivotal 24-week clinical trial involving 379 healthy women aged 18-40 years. This study demonstrated that Beyaz significantly increased folate levels in both red blood cells and plasma compared to YAZ[1][4].

Pricing and Cost Considerations

The cost of Beyaz can be substantial, with a supply of 84 tablets costing around $776, depending on the pharmacy. However, generic versions and patient assistance programs can significantly reduce this cost. For example, a generic version of Beyaz can cost as low as $172.10 for 84 tablets[2].

Patient Assistance and Copay Programs

To make Beyaz more accessible, patient assistance programs (PAPs) and copay cards are available. These programs, often sponsored by pharmaceutical companies, offer cost-free or discounted medicines to individuals with low income or those who are uninsured or under-insured[2].

Market Competition and Differentiation

Beyaz differentiates itself from other oral contraceptives by its unique combination of hormonal ingredients and folate supplementation. This differentiation can attract women who are concerned about folate levels and the risk of neural tube defects, providing a competitive edge in the market[1].

Risk-Benefit Assessment

While Beyaz offers several benefits, it also comes with significant risks, including the potential for blood clots, stroke, and heart attack, particularly during the first year of use. Women with certain medical conditions, such as blood clots, certain cancers, heart attack or stroke history, or kidney, liver, or adrenal disease, should not take Beyaz. The drug also contains drospirenone, which can increase potassium levels, necessitating careful monitoring in high-risk patients[1][5].

Financial Impact on Consumers

For consumers, the financial impact of using Beyaz can be mitigated through various means:

• Discount Cards: The Drugs.com discount card can save consumers up to 80% on the cost of Beyaz[2].
• Generic Options: Generic versions of Beyaz are available at significantly lower prices[2].
• Patient Assistance Programs: These programs can provide cost-free or discounted medicines to eligible individuals[2].

Market Trends and Projections

While specific market projections for Beyaz are not widely available, the broader market for contraceptives and women's health products continues to evolve. The demand for contraceptives that offer additional health benefits, such as folate supplementation, is likely to remain strong, driven by consumer preferences for comprehensive health solutions.

Regulatory Environment

The regulatory environment for Beyaz is stringent, with the FDA closely monitoring its safety and efficacy. The drug's approval and continued use are contingent on meeting strict clinical and safety standards, which can impact its market dynamics and financial trajectory[1][4].

Consumer Awareness and Education

Consumer awareness and education play a crucial role in the market dynamics of Beyaz. Healthcare providers must inform women about the benefits and risks of the drug, ensuring that they make informed decisions. Bayer's marketing efforts, such as highlighting the unique folate supplementation benefit, also contribute to consumer awareness and adoption[1].

Key Takeaways

• Unique Indications: Beyaz is the first and only oral contraceptive approved to raise folate levels, reducing the risk of neural tube defects.
• Pricing and Accessibility: The drug is available at various price points, with generic options and patient assistance programs making it more accessible.
• Risk-Benefit Assessment: While offering several benefits, Beyaz comes with significant health risks that must be carefully managed.
• Market Differentiation: The combination of hormonal ingredients and folate supplementation differentiates Beyaz in the market.
• Regulatory Compliance: The drug must meet strict FDA standards for safety and efficacy.

FAQs

What are the primary indications for Beyaz?

Beyaz is indicated for the prevention of pregnancy, treatment of symptoms of premenstrual dysphoric disorder (PMDD), treatment of moderate acne, and raising folate levels to reduce the risk of neural tube defects[1].

How does Beyaz differ from other oral contraceptives?

Beyaz is unique because it combines hormonal ingredients with levomefolate calcium, which raises folate levels in women, reducing the risk of neural tube defects[1].

What are the potential health risks associated with Beyaz?

Beyaz can increase the risk of blood clots, stroke, and heart attack, particularly during the first year of use. It also carries risks related to hyperkalemia, liver disease, and other conditions[1][5].

How can consumers reduce the cost of Beyaz?

Consumers can use discount cards, opt for generic versions, and utilize patient assistance programs to reduce the cost of Beyaz[2].

Is Beyaz suitable for all women?

No, Beyaz is not suitable for women with certain medical conditions, such as blood clots, certain cancers, heart attack or stroke history, or kidney, liver, or adrenal disease. Women should consult their healthcare provider to determine if Beyaz is appropriate for them[1][5].

Sources

1. U.S. FDA Approves New Oral Contraceptive That Also Raises Folate Levels - PR Newswire
2. Beyaz Prices, Coupons, Copay Cards & Patient Assistance - Drugs.com
3. Antibody Drugs: Technologies and Global Markets - BCC Research
4. Beyaz Clinical PREA - FDA
5. Beyaz Label - FDA